SERVICES Pharmacovigilance

The FDA Group provides life science companies access to highly skilled consultants who can handle a wide range of pharmacovigilance projects and needs. Our consultants, many of whom are former FDA, are experts in the science and activities related to detecting, evaluating, understanding, and preventing adverse effects associated with pharmaceutical and medical device products. Teams work with us when they want to ensure the safety of their products throughout their lifecycle. We help you bring products to market and keep them there.

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FUNCTIONAL AREA Pharmacovigilance System Development and Maintenance

Building and maintaining an effective pharmacovigilance system is critical for ensuring the safety of your products. Our services in this area include, but are not limited to:

  • Standard Operating Procedure (SOP) Development and Review

    Creating and updating SOPs and working practices to support all PV activities within your organization.|

  • Safety Data Exchange Agreements

    Authoring and maintaining agreements to ensure accurate and timely safety data exchange.

  • Company Core Datasheet (CCDS) Maintenance

    Development and governance of labeling committees and management of safety variations and urgent safety restrictions.

  • Safety Database Management

    Consultancy support for safety database due diligence, set-up, validation, and data migration activities.

  • Global Safety Committee Activities

    Management and support of safety committees to oversee safety signal management and risk minimization activities.

  • PV Quality Management System

    Design and/or maintenance of quality management systems to ensure compliance and efficiency in PV activities.

Functional Area Operational Pharmacovigilance Support

Managing day-to-day PV activities can be complex and resource-intensive. Our experienced consultants provide comprehensive support, ensuring all aspects of your PV operations run smoothly. Our services in this area include, but are not limited to:

  • Handling Safety Information

    Support for managing safety information from product quality complaints, medical inquiries, and solicited activities (e.g., registries, market research, patient support programs, company-sponsored social media activities).

  • Adverse Event Management

    Development of adverse event and pregnancy forms. Processing, analysis, reporting, and follow-up on adverse events as well as AE reporting requirements training.

  • Clinical Trial Support

    Review and input into clinical trial protocols, investigator brochures, clinical study reports, safety management plans, and medical monitoring plans.

  • Pharmacovigilance Audits

    Conducting on-site or remote audits of internal global and affiliate PV departments, as well as audits of contractual partners and providers.

  • Medical Information Management

    Providing medical information support and managing medical inquiries.

  • Aggregate Safety Reporting

    Preparation of global aggregate safety reports, including DSUR/ASR, PSUR/PBRER/PADER.

Functional Area Advanced Pharmacovigilance Consulting

Our resources also provide strategic oversight and specialized expertise to enhance your PV system. Our services in this area include, but are not limited to:

  • Signal Management

    Detection, evaluation, and management of safety signals to identify and mitigate potential risks.

  • Risk Management Plans (RMP) and REMS

    Development and maintenance of risk management plans and risk evaluation and mitigation strategies.

  • Benefit-Risk Communications

    Providing clear and effective communications with competent authorities regarding benefit-risk assessments.

  • Regulatory Inspection Support

    On-site or remote support before, during, and after regulatory inspections to ensure compliance and readiness, including CAPA plan development and management, and through completion.

  • Strategic PV Consulting

    High-level strategic PV assessment, analysis, and oversight to ensure your PV system is robust, compliant, and responsive to evolving safety needs.

  • Safety Variations and Urgent Safety Restrictions

    Management of safety variations and implementation of urgent safety restrictions to ensure ongoing product safety.

Pharmacovigilance Case Study Long-Term Quality System and Pharmacovigilance Staff Augmentation

Learn how The FDA Group partnered with a large clinical service company to manage its QMS remediation efforts and fulfill long-term staffing assignments for two vital roles in the management of the company’s quality and pharmacovigilance functions. This case study demonstrates the value of our convenient, cost-effective workforce model that circumvents the administrative costs and burdens of traditional hiring.

Read the case study (PDF) »

Engagement Models


Get access to expert consultants as well as contingent or direct hire candidate search and placement services. We specialize in the entire range of the resourcing process, giving you a breadth of expertise that has become increasingly hard to find in the life science industry.

ENGAGEMENT MODEL Consulting Projects

Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.

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ENGAGEMENT MODEL Staff Augmentation

Get contracted full-time consultant (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.

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Engagement Model FTE Recruitment

We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in specialized, competitive areas.

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Engagement Model Functional Service Program

The Functional Service Program (FSP) is a bundled engagement option that consolidates your externally-sourced projects through a single vendor in The FDA Group. By streamlining vendor management, our FSP eliminates inefficiency, reduces budget overruns, and provides high-quality services from the industry's top talent. Discounts scale with the size and duration of the service package and include a Total Quality Guarantee to ensure reliable service.

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Why work with The FDA Group?

  • Exclusive life science focus and expertise
  • Dedicated account management team
  • Right resource, first time (95% success)
  • 97% client satisfaction
  • Total Quality Guarantee

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Our Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Resources Definition

  • Background And Expertise
  • Location Of Resource
  • Rate Rightsizing

Proprietary Resource Selection Process

  • In-House Subject Matter Experts
  • Recruiting Team External Search
  • Resource Identification

Resource Presentation

  • CV And Rate
  • Perfect Match Summary
  • Interview Call Coordination

Agreement Processing

  • MSA And Addendums
  • Supplier Qualification
  • Kickoff Coordination

Account Management

  • Project Management Of Resource
  • Satisfaction Management For Client
  • Total Quality Guarantee

Contact us and get the conversation started.

Our resources can be utilized to meet the wide range of pharmacovigilance and postmarket requirements, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.

Please contact us to learn more about fulfilling specific pharmacovigilance resourcing needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.